Drug Safety

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

Individuals looking to quit smoking may turn to popular smoking-cessation drugs like Chantix (varenicline). Almost everyone has seen the commercials for Chantix, where a handful of people indicate that the drug has helped...more

The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013.
After three rounds of...more

Use of the selective serotonin reuptake inhibitor (SSRI) antidepressant Zoloft during the first trimester of pregnancy can increase a child’s risk of being born with serious heart defects or other birth defects. ...more

The Food and Drug Administration has warned that women who use the seizure and migraine drug Depakote while pregnant are more likely to give birth to a child with major birth defects than those who use other seizure drugs. ...more

The FDA is warning the public that treatment with chronic, high doses of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set of birth defects in infants. Diflucan is...more

Bloomberg News reported that GlaxoSmithKline P.L.C. has agreed to pay $1 billion to injured consumers to resolve more than 800 cases involving the antidepressant Paxil. The medication has been in use in the U.S. since 1992....more